NHS SCOTLAND
Providing advice about the status of all newly licensed medicines
SMC ISSUES ADVICE ON NEW DRUGS
The Scottish Medicines Consortium (SMC) today (Monday) accepted the following new drugs for use within NHSScotland:
Further Details:
TENOFOVIR (VIREAD)
Tenofovir has been shown to be significantly more effective than another nucleoside reverse transcriptase inhibitor in achieving a complete composite response (virological plus histological response) in a greater proportion of patients with chronic hepatitis B infection with HBeAg positive and HBeAg negative disease.
The manufacturer estimated that using tenofovir first-line in 23 treatment-naïve patients per annum instead of another nucleoside agent would have a net budget impact of £4k in year 1, rising to £20k in year 5. If it is also adopted as second-line therapy for patients who develop resistance, the net budget impact of treating 28 patients per annum was estimated at £5k in year 1 rising to £25k in year 5. If tenofovir is used in 25 additional patients who do not currently receive any nucleoside therapy, there would be an additional budget impact of £76k in year 1 rising to £388k in year 5.
Notes for editors – Glossary:
1. Hepatitis B – A disease caused by a virus that attacks the liver. The virus can cause lifelong infection, cirrhosis of the liver, liver cancer, liver failure, and can be fatal.
2. Fibrosis – The development of excessive tissue.
Notes for editors – About SMC:
1. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) in Scotland about the use of all newly licensed medicines, all new formulations of existing medicines and any major new indications for established products. It does this after new medicines have been licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) / European Medicines Evaluation Agency (EMEA).
2. The SMC process encourages pharmaceutical manufacturers to make a submission before a product is launched. The aim is to issue advice as soon as possible after the launch of a product.
3. Membership of the SMC has been derived from NHS Boards across Scotland. Membership is wide ranging across multi-disciplines of NHS Scotland and also includes members of the Association of British Pharmaceutical Industry (ABPI), and patient and voluntary group representatives.
4. This advice represents the views of the Scottish Medicines Consortium and was arrived at after careful consideration of the available evidence. Health professionals are expected to take due account of this recommendation when exercising their clinical judgement. This recommendation does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
For further information, contact Stephen Ferguson on 07779 329 689 or Colin McAllister on 07813 095930